ANDA 085186

NOSTRUM LABS INC

FDA Drug Application

Application #085186

Application Sponsors

ANDA 085186

NOSTRUM LABS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION, ELIXIR;ORAL

80MG/15ML

0

ELIXOPHYLLIN

THEOPHYLLINE

FDA Submissions

	ORIG	1	AP	1979-01-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1982-03-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1987-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1987-02-06
LABELING; Labeling	SUPPL	13	AP	1989-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1993-02-22
LABELING; Labeling	SUPPL	18	AP	1999-02-18
LABELING; Labeling	SUPPL	25	AP	2014-06-26	STANDARD

Submissions Property Types

SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	17	Null	0
SUPPL	25	Null	15

TE Codes

001

Prescription

AA

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85186
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELIXOPHYLLIN","activeIngredients":"THEOPHYLLINE","strength":"80MG\/15ML","dosageForm":"SOLUTION, ELIXIR;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ELIXOPHYLLIN","submission":"THEOPHYLLINE","actionType":"80MG\/15ML","submissionClassification":"SOLUTION, ELIXIR;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)